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Search / Trial NCT05863676

Ovarian Tissue Cryopreservation in the Setting of Gender-affirming Therapy

Launched by UNIVERSITY OF PITTSBURGH · May 15, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Fertility Fertility Preservation Infertility Gender Affirming Gender Diverse Non Binary Ovary

ClinConnect Summary

**Summary of the Clinical Trial: Ovarian Tissue Cryopreservation in the Setting of Gender-affirming Therapy**

This clinical trial is focused on helping individuals in the gender-diverse community preserve their fertility. Specifically, it aims to improve the methods used to freeze ovarian tissue, which can be important for those undergoing gender-affirming treatment. The study will look at how various factors, like past hormone treatments, might affect the success of these freezing techniques.

To participate, individuals must be female and over the age of 9, diagnosed with gender dysphoria, and either currently receiving or planning to start hormone treatments. For those aged 18 and older, participation is also open if they are scheduled for gender-affirming surgery that involves removing the ovaries. Participants can expect to undergo procedures related to ovarian tissue preservation, and the study is currently recruiting participants. It’s important to note that individuals with certain psychological conditions or serious medical issues may not be eligible for the trial. This research could play a crucial role in supporting the fertility choices of those undergoing gender-affirming therapies.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:Two Categories of participants will be eligible for this study.
  • Category 1 participants must have all criteria listed below:
  • Patient with ovaries over the age of 9
  • Diagnosed with gender dysphoria; currently on or imminently planning to start gender affirming treatment (hormone blockers or gender-affirming hormones)
  • Have a clinical referral for fertility preservation from their primary care physician
  • Unwilling to undergo natal puberty or, for patients who have gone through puberty, unwilling to discontinue hormone suppression and/or hormone replacement therapy.
  • Category 2 participants only fall into this category if they are undergoing gender-affirming surgery. They must have all criteria listed below:
  • Patient is 18+ years old
  • Diagnosed with gender dysphoria
  • Unwilling to undergo natal puberty, or for patients who have gone through puberty, be unwilling to discontinue hormone suppression and/or sex steroid (estrogen) therapy.
  • Will be undergoing gender affirming surgery that involves removal of the ovaries.
  • Exclusion Criteria:
  • Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
  • Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery.

About University Of Pittsburgh

The University of Pittsburgh is a leading research institution known for its commitment to advancing medical science and improving patient care through innovative clinical trials. With a robust infrastructure for research and a multidisciplinary approach, the university fosters collaboration among experts in various fields, facilitating the development of novel therapies and interventions. Its clinical trial programs emphasize ethical standards, patient safety, and the integration of cutting-edge technology, making the University of Pittsburgh a pivotal contributor to the landscape of clinical research and a trusted partner in the pursuit of health advancements.

Locations

Pittsburgh, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Kyle Orwig, PhD

Principal Investigator

University of Pittsburgh/ University of Pittsburgh Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported